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Post-First Progression Use of Bevacizumab in Metastatic Colorectal Cancer (mCRC)

NCT ID: NCT00862342

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-06-30

Brief Summary

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Bevacizumab beyond progression has been proven to be safe in the community setting (BRiTE) and in the post-marketing study (BEAT), and confirmed its efficacy and safety in the first line with all regimens of chemotherapy. A total of 1,953 patients were treated in BRiTE. At median follow-up of 17.5 mo, there were 1,369 1st PD and 839 deaths. Among patients with 1st PD, 65.2% received any 2nd-line chemotherapy, 34.8% received cetuximab, and 53.8% received BBP. In a multivariate analysis, Bevacizumab beyond first progression and exposure to any 2nd-line chemotherapy were independently associated with increased overall survival (both p \< 0.0001). Bevacizumab beyond progression appears to be associated with longer overall in BRiTE.

The investigators planned a prospective study to prove this phenomenon of bevacizumab beyond progression.

Detailed Description

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Patients should have been treated with bevacizumab plus chemotherapy as a 1st line treatment, and after 1st progression, these patients will be accrued in this study of bevacizumab plus chemotherapy as a 2nd line treatment, and the combined chemotherapy will be chosen by physician's decision in consider with previous chemotherapy.

Conditions

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Metastatic Colorectal Cancer

Keywords

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colorectal cancer Bevacizumab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab

Bevacizumab continuation plus chemotherapy in patients who have failed previous bevacizumab plus other chemotherapy

Group Type EXPERIMENTAL

Bevacizumab (Avastin)

Intervention Type DRUG

Bevacizumab plus chemotherapy (chemotherapy will be chosen by physician's decision)

Interventions

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Bevacizumab (Avastin)

Bevacizumab plus chemotherapy (chemotherapy will be chosen by physician's decision)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically documented colorectal adenocarcinoma
* Progression during first-line bevacizumab containing chemotherapy within 3 months
* No serious toxicity to bevacizumab of 1st line treatment
* Unresectable metastases
* Uni-dimensional measurable lesion(s) by RECIST
* Age over 18 years old
* ECOG 0-2
* Adequate organ functions by clinical laboratory exams

Exclusion Criteria

* Other tumor type than adenocarcinoma
* CNS metastases
* GI bleeding
* Hypersensitivity to any of chemotherapeutic agents
* Prior use of cetuximab or other targeted agents other than bevacizumab
* Major surgery within 6 weeks
* Other serious illness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae Won Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae Won Kim, M.D.

Role: STUDY_CHAIR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, Songpa-gu, South Korea

Site Status

Countries

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South Korea

References

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Hong YS, Lee J, Kim KP, Lee JL, Park YS, Park JO, Park SH, Kim SY, Baek JY, Kim JH, Lee KW, Kim TY, Kim TW. Multicenter phase II study of second-line bevacizumab plus doublet combination chemotherapy in patients with metastatic colorectal cancer progressed after upfront bevacizumab plus doublet combination chemotherapy. Invest New Drugs. 2013 Feb;31(1):183-91. doi: 10.1007/s10637-012-9853-3. Epub 2012 Jul 11.

Reference Type RESULT
PMID: 22782485 (View on PubMed)

Other Identifiers

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AMC-2008-0487

Identifier Type: -

Identifier Source: org_study_id